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Quality Engineer I

4 months ago

North Haven, United States LanceSoft Full time

JOB DESCRIPTIONTop 3 technical skills that you are required for the role:Validation (IQ, OQ, PQ)Corrective Action / Preventive Action (CAPA)Support of manufacturing processEducation Required: Bachelors Degree in Engineering or technical fieldYears Experience Required: 0-3Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hoursDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite (North Haven, CT)What is your timeline for scheduling interviews? ASAPWhat product line will this person support? Advanced Surgical InstrumentsThis position will support the Advanced Surgical Instruments Manufacturing business within ***s Surgical Innovations group located in North Haven, CT. This role is responsible for ensuring all aspects of the manufacturing process produce products to the highest possible reliability and quality. Some responsibilities include investigating and evaluating nonconforming devices and process identified during the manufacturing process as well as determining and implementing robust corrective actions to address the issues. Additionally, this role is responsible for identifying and validating improvements to reduce cycle time and improve overall production cell reliability. Monitoring and evaluation of complaints on devices used during surgical procedures is also required.A Day in the LifeResponsibilities may include the following and other duties may be assigned.On site support of daily manufacturing operations including troubleshooting of equipment, investigation of defects, and validation of equipment/processes.Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.Collaborates with engineering and manufacturing functions to ensure quality standards are in place.Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.Must Have: Minimum RequirementsBachelors degree required0 years of experience requiredNice to HaveExperience working in a fast paced Manufacturing environmentValidation Experience (IQ, OQ, TMV, PQ)CAPA (Corrective Action / Preventive Action) ExperienceFamiliarity with Minitab Statistical SoftwareSix Sigma TrainingAbout ***The standard *** statement will auto populate.Physical Job RequirementsThe standard *** statement will auto populate.